Status:
COMPLETED
Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
Lead Sponsor:
Sanofi
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram. Th...
Eligibility Criteria
Inclusion
- Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score =\> 30
Exclusion
- Patient is at immediate risk for suicidal behavior
- Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
- Patients with a current depressive episode secondary to a general medical disorder
- Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
- Patients with severe or unstable concomitant medical conditions
- Pregnant, breastfeeding, or likely to become pregnant during the study
- Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram
- The investigator will evaluate whether there are other reasons why a patient may not participate.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00432614
Start Date
January 1 2007
End Date
February 1 2008
Last Update
March 25 2009
Active Locations (13)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Tatari, Estonia
3
Sanofi-Aventis Administrative Office
Helsinki, Finland
4
Sanofi-Aventis Administrative Office
Paris, France